Manager, Technical Operations

Req ID #:  49351
Location: 

Horsham, PA, US, 19044-1241

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

 

BASIC SUMMARY:  

Manage and coordinate study related activities of research technical staff through supervisors to ensure compliance with the protocol and applicable SOP’s and maintain the raw data for nonclinical studies.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Manage technical staff performing studies in compliance with GLP regulations, SOPs, safety procedures and biosafety protocols.
  • Work closely with Study Directors, Study Coordinator, Data Management, Animal Care and technical staff in planning, conducting and reporting of studies.
  • Assist Study Directors and Study Coordinators in preparing responses to both internal and Sponsor Quality Assurance Audits.
  • Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GLP requirements.
  • Ensure study parameters are recorded as required by protocol.
  • Ensure and/or perform rodent physical examinations, randomization and determine suitability for study assignment.
  • Review raw data and maintenance records as required by Standard Operating Procedures.
  • Monitor post in-life phase activities to ensure the raw data records are complete and ready for paginating and/or archiving and that the computer database for each study is accurate.
  • Perform study edits.
  • Request and review periodic summarization of data.
  • Determine methods and procedures on new assignments and may provide guidance to assisting personnel.
  • Provide direct daily supervision and review work of assigned departmental employees to ensure accuracy and to ensure adherence to pertinent departmental policies, practices, and procedures.  Schedule and prioritize workload of group members.
  • Assist in the interview and selection of qualified non-exempt personnel.  Recom­mend personnel actions, including hiring, promotions and raises.  Partner with Human Resources and depart­mental management to assist in the handling of disciplinary issues.  Draft appropriate personnel action paperwork.
  • Identify training and development needs of direct reports.  Assist in the development, implementation and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training.  Monitor performance of direct reports.  Provide regular coaching and counseling. 
  • Assist in preparation and delivery of salary and performance reviews of direct reports.
  • Schedule overtime as authorized.  Review and approve time cards.  Coordinate vacation/time off schedules.
  • Recommend short-range operating objectives, organizational structure of direct reports and staffing requirements.  Assist in the development of a departmental plan for backup and succession of key technical personnel.
  • May assist in development of departmental budget.
  • Ensure optimum performance of group function.  Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
  • Assist in the development, maintenance and communication of departmental systems and SOPs.  Assist in the development and communication of job descriptions for subordinate positions.
  • Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition. 
  • Perform other related duties as assigned by supervisor.

 

QUALIFICATIONS:

  • Education:  . Bachelor of Science degree in a life science, preferably in Biology with relevant animal science courses, or relevant animal science education and experience.
  • Experience:  Four to six years’ experience in a GLP environment and experience with research and investigative procedures, techniques and literature.  Three or more years of supervisory experience desired. 
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure:  ALAT required, LAT preferred
  • Other:  Ability to organize, prioritize work, lead, and meet deadlines. Computer literacy including word processing and spreadsheet software.
Job Summary

Provides leadership and management to the Technical Operations Department.  This position is responsible for oversight of technical leaders and monitoring the overall conduct of technical activities performed in support of non-clinical research studies.   

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

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